Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
• Generic Name: Coronary drug-eluting stent
• Applicant: Abbott Vascular; 3200 Lakeside Dr.; Santa Clara, CA 95054
• PMA Number: P110019
• Supplement Number: S010
• Date Received: 01/31/2012
• Decision Date: 02/21/2012
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
MODIFICATION OF A MARKER ALIGNMENT TEMPLATE; AND A CHANGE TO THE IN-PROCESS ACCEPTANCE CRITERIA FOR ONE BALLOON LENGTH SIZE.